Context Therapeutics Announces Preclinical Data Demonstrating Differentiated and Active Profile of its Claudin 6-Targeted Bispecific Antibody CTIM-76

CTIM-76 exhibits dose-proportional tumor responses and safety in preclinical models

Benchmarking studies comparing CTIM-76 with clinical-stage CLDN6 therapies support CTIM-76's differentiated product profile

CTIM-76 IND filing on track for late Q1 2024

Data to be presented at SITC 38^th Annual Meeting on November 3^rd

PHILADELPHIA, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced encouraging preclinical data regarding the Company’s preclinical asset, CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.

Findings from Context’s research team, in conjunction with development partner Integral Molecular, illustrate the potential of CTIM-76 to treat CLDN6-positive tumors. Notably:

• CTIM-76 was shown to have high potency and target selectivity in both binding and cytotoxicity assays.
• In in vivo xenograft experiments, CTIM-76 induced dose-proportional tumor regressions and was well tolerated.
• In IND-enabling toxicology studies, CTIM-76 was well tolerated, and a potential first-in-human dose was identified.
• Clones of clinical-stage molecules TORL-1-23 and AMG-794 were generated for benchmarking purposes. In comparison studies, TORL-1-23 activity appeared dependent upon high CLDN6 expression whereas CTIM-76 activity was retained across a range of cell lines expressing with low through high CLDN6. Additionally, CTIM-76 demonstrated ten-fold higher potency than AMG-794 in in vitro cytotoxicity and cytokine activation.

“It is estimated that there are 70,000 patients with CLDN6-positive metastatic solid tumors in the United States, and no approved targeted treatment options exist,” said Martin Lehr, CEO of Context. “We’re encouraged by the promise CTIM-76 has shown with these first in vivo data, which reinforce the selectivity and potency seen in earlier in vitro data and demonstrate CTIM-76’s ability to induce complete tumor regressions across multiple dose levels. Moreover, our comparison to clones of clinical-stage molecules demonstrates CTIM-76’s ability to address potential target density and toxicity challenges associated with first-generation approaches, as well as highlights CTIM-76’s pharmacologically distinct profile and broad therapeutic potential.”